DETAILED ACTION
This Office Action is in response to the communication dated 03 February 2006 concerning Application No. 18/076,915 filed on 07 December 2022.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 1, 3-9, 11-17, and 19-24 are pending and currently under consideration for patentability; claims 1, 5, 9, 13, 17, and 21 have been amended; claims 2, 10, and 18 have been cancelled.
Response to Arguments
Applicant’s arguments dated the 03 February 2026 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to further recite altering a parameter of the therapeutic stimulus provided by the stimulus source in response to receiving the measured neural response to bring the measured neural response closer to a target value, with similar limitations appearing in previously presented claims 2, 10, and 18. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Applicant argues that Gliner’s measured neural responses are in response to a test stimulation procedure and not a therapeutic stimulation presented. Applicant reiterates this argument throughout the discussion, consistently directing Examiner paragraphs [0029] and [0024] of Gliner which describe the differences between test stimuli and therapeutic/treatment stimuli. The Examiner does not dispute Applicant’s contention that Gliner distinguishes between a test stimulation procedure and applying a subsequent therapeutic stimulus. However, the Examiner respectfully submits that for the purposes of measuring the patient’s responses to the stimulus, the test stimulation and subsequent therapeutic stimulation described by Gliner act in substantially the same manner. For example, the test stimuli provided by Gliner are all potential therapeutic stimuli, as they hopefully will elicit a beneficial therapeutic outcome on the patient. Although the test stimulation procedure may be used to optimize the subsequent treatment stimulus, the two are still used in an overall therapeutic manner. As Gliner even states, “the patient is subsequently treated using a stimulation signal having parameters identical to those of the test stimulation signal, which the possible exception of stimulation signal amplitude, which may be a predetermined value based on the neural stimulation threshold” ([0013]). In this, Gliner shows the similarity, or even the identical, nature of the test stimulation signal and subsequent therapeutic stimulation signal. Applicant cites this same passage in their arguments as well (p. 11 of the Arguments). Therefore, even though Gliner states that different stimuli are tested first, and then used to derive an optimal therapeutic stimulus subsequently delivered to the patient, the fact remains that the test stimuli are still provided to the patient and the neural responses to the test stimuli are measured. Simply labeling the first set of stimulation signals as “test” stimuli and subsequent stimulation signals as a “treatment” stimuli does not mitigate the fact that Gliner’s method measures the responses to both of these stimulation signals. Therefore, the Examiner respectfully maintains that Panken in view of Gliner and King suggests the claimed limitations.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-5, 8, 9, 11-13, 16, 17, 19-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Panken et al. (US 2010/0010388 A1) in view of Gliner et al. (US 2004/0019370 A1) and King (US 5,702,429).
Independent Claims 1, 9, and 17
Regarding claims 1 and 17, Panken describes an implantable device for suppressing pain by applying therapeutic neural stimuli ([0003], [0077]), the implantable device comprising
a plurality of electrodes including at least one stimulus electrode ([0077]) and at least one sense electrode (suggested in [0177])
a stimulus source for providing therapeutic stimuli to be delivered from the at least one stimulus electrode to an electrically excitable tissue in the spinal cord of a patient ([0077])
an accelerometer configured to measure one or more of orientation and movement of the implantable device ([0143])
a control unit configured to
receive a measured response from measurement circuitry ([0063])
effect feedback control of the stimuli provided by the stimulus source by altering a parameter of the therapeutic stimulus provided by the stimulus source in response to receiving the measured neural response ([0024]) to bring the measured neural response closer to a target value ([0013], [0024]), wherein the feedback control takes into account the orientation and the movement measured by the accelerometer ([0063], [0087])
Specifically regarding the incorporation of at least one sense electrode, the Examiner respectfully directs Applicant to Panken’s paragraph [0177], which describes implantable medical devices “that are generally dedicated to sensing or monitoring.” Panken also describes that “an implantable monitoring device may be implanted in conjunction with an implantable stimulation device, and be configured to evaluate sensing integrity of leads or electrodes associated with the implantable monitoring device based on sensed signals evoked by delivery of stimulation by the implantable stimulation device” ([0177], emphasis added). Based on this, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate at least one sense electrode as part of the plurality of electrodes described by Panken, as doing so advantageously allows the resulting device to appropriately monitor the evoked responses to the stimulation and thereby adjust the stimulation as necessary. Such a configuration also would allow the system to dynamically adjust the stimulation according to the evoked response, thereby optimizing the stimulation for a specific scenario.
Regarding claims 1 and 17, although Panken describes providing stimulation to the spinal cord of a patient, Panken does not explicitly disclose providing stimuli to excitable tissue in the dorsal column of the patient. Panken also does not describe measurement circuitry for measuring neural responses sensed at the at least one sense electrode, each neural response evoked by and in response to a therapeutic stimulus, wherein the accelerometer measurements are obtained simultaneously with the measurement of a neural response of the measured neural responses, wherein the control unit controls the stimulus source to provide the therapeutic stimulus, receives the measured neural response, and effects feedback control of a subsequent therapeutic stimulus provided by the stimulus source in response to receiving the measured neural response.
Regarding measuring the evoked neural responses, Gliner also describes an implantable device configured to apply therapeutic neural stimuli ([0021]), including measurement circuitry for measuring neural responses sensed at the at least one sense electrode, each neural response evoked by and in response to a therapeutic stimulus ([0029]), and a control unit ([0025]) configured to control the stimulus source to provide a therapeutic stimulus ([0024]: "the stimulus unit 120 may additionally perform, direct, and/or facilitate neural stimulation treatment procedures”; [0025]: "the controller 130 may be implemented as a computer or microcontroller...that performs, directs, and/or facilitates neural stimulation threshold test procedures"), receive the measured neural response from the measurement circuitry ([0029], sensing unit 180 coupled to stimulus unit 120 via link 186), and effect feedback control of a subsequent therapeutic stimulus provided by the stimulus source in response to receiving the measured neural response ([0024]: "the stimulus unit 120 may additionally perform, direct, and/or facilitate neural stimulation treatment procedures to treat a particular neurological condition and/or affect or influence a given type of neural activity...the treatment stimulation signal, for example, is typically at a level or amplitude that corresponds to a result obtained during neural stimulation threshold test procedures"). As Gliner is also directed towards an implantable medical device configured to apply therapeutic neural stimuli and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate evoked response measurement and control steps similar to those described by Gliner when using the method described by Panken, as doing so advantageously allows the resulting method to obtain the optimal stimulation parameters based on testing various stimulation protocols and measuring the respective responses.
Regarding the accelerometer measurements being obtained simultaneously with the measurement of a neural response of the measured neural responses, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to obtain the accelerometer measurements simultaneously with the evoked neural responses, as doing so advantageously allows the resulting method to account for the orientation and movement of the implantable medical device when deriving the optimal stimulation parameters.
Regarding providing stimuli to the dorsal column, King also describes an implantable medical device for suppressing pain by applying a neural stimulus (col 1:12-16) including providing stimuli to excitable tissue in the dorsal column of the patient (col 3:23-30). As King is also directed towards an implantable device that may be used to suppress pain and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a stimulation site similar to that described by King when using the system described by Panken, as doing so advantageously allows the resulting method to better target the therapy to specific areas of the patient’s body.
Regarding claim 9, Panken describes a method of suppressing pain by applying therapeutic neural stimuli ([0003], [0077]), the method comprising
delivering a therapeutic stimulus from at least one stimulus electrode to an electrically excitable tissue in the spinal cord of a patient ([0077])
measuring one or more of orientation and movement of the at least one stimulus electrode ([0143])
effecting feedback control of therapeutic stimulus delivery, wherein the feedback control takes into account the measured orientation and movement ([0063], [0087])
wherein effecting feedback control of the subsequent therapeutic stimulus delivery comprises altering a parameter of the therapeutic stimulus in response to receiving the measured neural response ([0024]) to bring the measured neural response closer to a target value ([0013], [0024])
Regarding claim 9, although Panken describes providing stimulation to the spinal cord of a patient, Panken does not explicitly disclose providing stimuli to excitable tissue in the dorsal column of the patient. Panken also does not describe measuring a neural response sensed at at least one sense electrode and evoked in response to the therapeutic stimulus, wherein the orientation and movement of the stimulation electrode is measured simultaneously with the measurement of the neural response, and effecting feedback control of subsequent therapeutic stimulus delivery in response to receiving the measured neural response.
Regarding measuring the evoked neural responses, Gliner also describes a method of applying therapeutic neural stimuli ([0021]), including measuring a neural response sensed at at least one sense electrode and evoked in response to the therapeutic stimulus ([0029]), and effecting feedback control of subsequent therapeutic stimulus delivery in response to receiving the measured neural response ([0024]: "the stimulus unit 120 may additionally perform, direct, and/or facilitate neural stimulation treatment procedures to treat a particular neurological condition and/or affect or influence a given type of neural activity...the treatment stimulation signal, for example, is typically at a level or amplitude that corresponds to a result obtained during neural stimulation threshold test procedures"). As Gliner is also directed towards an implantable medical device configured to apply therapeutic neural stimuli and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate evoked response measurement and feedback control steps similar to those described by Gliner when using the method described by Panken, as doing so advantageously allows the resulting method to obtain the optimal stimulation parameters based on testing various stimulation protocols and measuring the respective responses.
Regarding the orientation and movement of the stimulation electrode being measured simultaneously with the measurement of the neural response, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to obtain the orientation and movement measurements simultaneously with the evoked neural responses, as doing so advantageously allows the resulting method to account for the orientation and movement of the electrode when deriving the optimal stimulation parameters.
Regarding providing stimuli to the dorsal column, King also describes an implantable medical device for suppressing pain by applying a neural stimulus (col 1:12-16) including providing stimuli to excitable tissue in the dorsal column of the patient (col 3:23-30). As King is also directed towards an implantable device that may be used to suppress pain and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a stimulation site similar to that described by King when using the system described by Panken, as doing so advantageously allows the resulting method to better target the therapy to specific areas of the patient’s body.
Dependent Claims 3-5, 8, 11-13, 16, 19-21, and 24
Regarding claims 3, 11, and 19, Panken describes wherein the control unit is configured to perform the feedback control in response to detecting at least a threshold physical movement by the patient based on, at least, the movement measured by the accelerometer ([0154], incorporation of an accepted tolerance in the activity parameter value; [0156], stability period before assigning a posture state).
Regarding claims 4, 12, and 20, Panken describes wherein the control unit is configured to enable the feedback control in response to detecting at least a threshold physical movement based on, at least, the movement measured by the accelerometer ([0154], incorporation of an accepted tolerance in the activity parameter value; [0156], stability period before assigning a posture state).
Regarding claims 5, 13, and 21, Panken describes wherein the control unit is configured to set one or more parameters of the feedback control based on an estimate of posture for the patient determined based on, at least, the orientation measured by the accelerometer ([0155] - [0156]).
Regarding claims 8, 16, and 24, Panken describes wherein the control unit is configured to select a parameter-selection algorithm, out of a plurality of parameter-selection algorithms, based on the movement measured by the accelerometer ([0070], [0098]).
Claims 7, 15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Panken in view of Gliner and King, further in view of Wahlstrand et al. (US 2006/0247739 A1).
Regarding claims 7, 15, and 23 Panken in view of Gliner and King suggests the implantable device of claim 1, the method of claim 9, and the neuromodulation system of claim 17, but Panken, Gliner, and King do not explicitly disclose wherein the control unit is further configured to adjust a rate at which neural response measurements are obtained based on a measure of patient activity determined based on, at least, one or more of the movement and the orientation measured by the accelerometer. However, Wahlstrand also describes an implantable neural stimulation device, including adjusting a rate at which neural response measurements are obtained based on a measure of patient activity ([0012] - [0014]) determined based on, at least, one or more of the movement and the orientation measured by an accelerometer ([0048] - [0049]). As Wahlstrand is also directed towards an implantable neural stimulation device and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate the feature of adjusting the neural response measurement rate based on patient movement, similar to that described by Wahlstrand, when using the device described by Panken, Gliner, and King, as doing so advantageously allows the resulting device to accurately capture patient data even at times of greater movement.
Allowable Subject Matter
Claims 6, 14, and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claims 6, 14, and 22, Panken describes wherein the one or more parameters of feedback control comprises a slow response threshold ([0150], determining velocity of patient’s motion; [0152], using the AC component of the accelerometer signal to derive information about patient motion, including the level, direction, and/or acceleration of the patient; [0252] - [0254], adjusting the search period and stability period as needed). However, Panken, Gliner, and King do not disclose or suggest wherein the slow response is a neural response associated with motor response that is observable at least 2 ms after the therapeutic stimulus. Applicant’s Specification provides the following guidance regarding this limitation at paragraphs [0122] and [0156], reproduced below.
[0122] FIG. 16 illustrates the evoked response in a sheep spinal cord, demonstrating fast and slow responses. The black dotted line is an electromyogram (EMG) trace recorded from an electrode implanted in the corresponding muscle. The Aβ activity is present in the 0 to 1.5 ms time window. Above a threshold stimulation current level, a slow response is observed 2 ms after stimulation. The slow response is the result of the activation of other neural elements. Activation of the Aδ fibres results in activation of the spinal reflex loop (nociceptive reflex) and can cause muscle contractions. Direct activation of motor neurons also will cause motor responses. Observation of the slow responses in animal experiments was accompanied by the observation of muscle twitching, while observation of the slow response in humans is observed only at uncomfortable stimulation levels.
[0156] The stimulus which is used to probe the slow response presence or absence is output at frequency which is not annoying to the recipient. The fast (<2 ms) response recorded is due to activation of Aβ fibres in the spinal cord, and the slow response observed accompanies unwanted, uncomfortable or undesirable stimulation (e.g. muscle fibre activation). Thus, the stimulus level should ideally be set between the fast response threshold value (Tf in FIG. 21) and the value at which an unwanted response is evoked.
The Examiner respectfully directs Applicant to the reference of Libbus (US 2006/0116797 A1), which is also directed towards an implantable device for applying therapeutic neural stimuli ([0007]). Libbus describes wherein inappropriate stimulation may lead to “undesired contractions or twitching” in the relevant muscles being targeted. However, Libbus does not disclose or suggest any of the neural elements or nerve fibers described by Applicant, and Libbus does not provide any teaching of the times at which the various responses may be observed. Therefore, although Libbus is cited as analogous and pertinent prior art, Libbus, either alone or in combination with the previously cited references, does not disclose or suggest “wherein the slow response is a neural response associated with motor response that is observable at least 2 ms after the therapeutic stimulus.”
Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
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Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Carl Layno, can be reached by telephone at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792